Ph3Summary /h3 pThe Product Expert (or Product Steward) owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in continued state of validation and continuously improving. Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provides second line technical/scientific process support. /p h3Major Accountabilities /h3 ul liMaintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC. /li liCreate and maintain a product specific Quality Risk Analysis (QRAs). /li liMonitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending. /li liEnsure inspection readiness for all process related aspects of assigned products. /li liTrack and evaluate product performance, trending, detect issues, implementation of CAPAs. /li liLead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams. /li liResponsible for ensuring the continued state of validation (process, cleaning, ongoing verification etc.). /li liProvide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed. /li liDesign and manage optimization projects. /li /ul h3Essential Requirements /h3 ul liDegree in Pharmacy, Pharmaceutical Technology, Chemistry, Chemical Engineering or equivalent scientific degree. /li li6-8 years of experience in Process Support/Process Expert roles within the MST department of a pharmaceutical company. /li liExtensive knowledge of GMP and analytical methods validation. /li liExperience of data handling and applied statistics. /li liFluent in English and Italian. /li /ul h3Why Novartis: /h3 pHelping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? /p h3Benefits and Rewards: /h3 pLearn about all the ways we’ll help you thrive personally and professionally. /p pRead our handbook (PDF 30 MB) /p /p #J-18808-Ljbffr